A little over a year ago, Congress ordered the Drug Enforcement Administration to combat the deadly abuse of legal painkillers by tightening up an arcane tool used to regulate the nation's opioid supply.
As opioid deaths have mounted, the "Aggregate Production Quota" for oxycodone and hydrocodone has been seized upon by lawmakers, state officials and the drug companies as a possible solution to the crisis, a way for the federal government to stamp out illegal drug "diversion" to the black market.
In bipartisan legislation co-sponsored by Sen. Richard Durbin, D-Ill., and passed by Congress in October 2018, lawmakers required the agency to consider diversion in setting the quota, along with overdose deaths and public health, in the hope that it might, in Durbin's words, "rein in the pharmaceutical industry's insatiable demand for excessive opioid quota increases."
The congressional action has set off a wider debate about how the nation determines its painkiller supply and whether more could have been done to stop the opioid epidemic. If the DEA had simply cut the supply, critics argued, then the deaths would have dropped as well.
The DEA quota system was created nearly five decades ago to ensure that drug manufacturers would have enough controlled substances each year for medical, scientific, research, industrial and export needs and the maintenance of reserve stocks. The idea is to prevent shortages but also to limit the amount to what is necessary. The system was never set up to stop diversion.
Current and former DEA officials say that using the quota to attack the epidemic would not work and could harm legitimate pain patients, citing practical difficulties in calculating a precise number that can be cut from the supply.
In a notice placed in the Federal Register on Sept. 12, the DEA said it tried to carry out the new process mandated by Congress and determined that it could cut only 57 kilograms of oxycodone out of a total supply of nearly 72,600 - less than one-tenth of 1%.
"What Congress wants to do will be virtually impossible," said John W. Partridge, a retired 28-year DEA veteran who helped to supervise the Diversion Control Division, which oversees the quota section. "It just infuriates me that you want to blame us for this. It's an easy out."
The DEA's notice brought more criticism, including a blistering letter Oct. 17 from Durbin to the DEA's administrator.
"The pharmaceutical industry flooded every corner of the country with 76 billion oxycodone and hydrocodone pills between 2006 and 2012 - outsized and unjustifiable numbers of painkillers shipped with DEA approval and awareness," Durbin wrote. "The statute is clear that DEA must exercise its quota authority to serve as a gatekeeper and weigh the public health impact of how many opioids it allows to be sold each year in the United States."
On Oct. 23, the DEA issued a notice of proposed rulemaking that sought comments on how to meet the requirements of the new law. On Monday, a multistate coalition responded with "16 specific ways the DEA can better account for diversion" when setting quotas. Among the proposals was a suggestion to use six national databases to better track opioid abuse, along with state databases and information about unused opioids turned in to authorities.
"The coalition acknowledges no data is perfect or all-inclusive, but its members contend there is still plenty of material that when reviewed from different angles can help the agency better account for diversion and thereby gain a more accurate picture of the nation's medical, scientific and industrial need," states a news release accompanying the proposals, which were filed by West Virginia Attorney General Patrick Morrisey and co-signed by his counterparts from Arkansas, Florida, Kentucky, Missouri and Nebraska.
In an interview with The Washington Post on Friday, Morrisey said: "The quota system has been plagued by so many challenges and neglect for a period of decades. This was a colossal failure in the enforcement of our drug system for many, many years."
The Government Accountability Office, the investigative arm of Congress, wrote in a 2016 report that the "process of setting quotas is very complex, requiring staff to weigh data from at least five different sources that may have contradictory information."
Under the Controlled Substances Act and federal regulations, the DEA sets the production quota for each class of controlled substance, such as oxycodone and hydrocodone, that are prescribed for legitimate patients but also carry a high risk of abuse. Scientists working in the DEA's United Nations Reporting and Quota Section make their determinations by conducting an analysis of a multitude of factors.
The DEA receives estimates from the Food and Drug Administration about what drug amount that agency believes should be manufactured based on legitimate medical needs. The DEA also analyzes requests from each drug manufacturer for its projected needs, product development, research and export, along with the amount of drugs still in its inventory. The primary factor is the number of prescriptions that were written by doctors and filled in the previous year, according to the DEA.
"Prescriptions drive the quota," said Ruth Carter, a 30-year veteran of the DEA who served as a senior official until retiring in June from the Diversion Control Division. She is now a consultant for lawyers suing the drug companies. "It's totally wrong that we could have controlled the epidemic by the quota," Carter said.
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The DEA sets two main quotas: the Aggregate Production Quota is the total amount of each drug that the agency allows to be manufactured - the whole pie, in the words of one DEA official. The Individual Manufacturing Quota represents each manufacturer's piece of the pie.
In an interview last year published in the Pharmacy Times, Joseph T. Rannazzisi, who ran the DEA's diversion division for a decade at the height of the crisis, called the system a "balancing act that is accomplished through a scientific and mathematical exercise conducted by DEA scientists." Rannazzisi signed off on quotas, along with the DEA administrator, between 2005 and 2015.
Rannazzisi said that the assertion that lowering quotas could have curtailed the epidemic was "based on misinformation, misunderstanding and a thirst for an immediate solution to a problem that has risen to epidemic proportions over a 20-year period." Rannazzisi said the only way to reduce quotas substantially is if prescriptions decrease. He said, for example, that a unilateral 20 percent cut could lead to shortages.
"You still have the same number of legitimate patients, overprescribed patients, and illegitimate patients accessing the drug from the same prescribers. If prescribing behavior does not change, the same number of individuals will be attempting to access the drug, but now there is 20% less drug to be shared."
Rannazzisi, who is now a paid expert for plaintiffs suing the drug companies, declined to comment for this article because of the ongoing litigation.
Kathleen J. Frydl, a historian and author of "The Drug Wars in America: 1940-1973," said that the DEA's quota system is "absolutely, fundamentally broken" and has called for more openness.
"It should not be the DEA by itself setting quotas," she told The Post. "This should be an interagency process that is transparent. All of us, public health activists, drug policy reformers, any number of people, should be able to watch and view how this process is unfolding - not just the very few people who know how this arcane process works."
Former DEA officials acknowledged that the agency struggled to confront the opioid epidemic. They said the understaffed diversion division was overmatched by the need to track nearly 1.8 million medical professionals, manufacturers, distributors and pharmacies.
They point to successes using tools other than the quota. Led by Rannizzisi, the DEA shut down illicit internet pharmacies and pill mills in Florida, and over a decade brought two dozen civil enforcement cases against drug distributors and manufacturers accused of failing to stop suspicious orders, resulting in nearly $500 million in fines.
In the years following these actions, prescriptions for opioids began to drop, falling nearly 30% between January 2017 and August 2019 for the seven most frequently diverted opioids, according to the DEA.
As the prescriptions dipped, quotas have been lowered, with oxycodone's dropping 6% in 2018. In September, the DEA proposed more quota cuts in 2020 - oxycodone by 9% and hydrocodone by 19%.
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Contradictory information about quotas has swirled around Capitol Hill for years.
In 2011, then-DEA administrator Michele Leonhart testified before Congress that the quota serves "the vital purpose of reducing the risk of diversion." A former official who spoke on the condition of anonymity to talk about internal deliberations said Leonhart was referring to only using thefts and seizures, not drug abuse and deaths, in setting the quota.
In 2015, around the peak of the epidemic, the GAO issued a report criticizing the DEA's quota system - for creating possible drug shortages. "In the last decade, shortages of drugs containing controlled substances, such as narcotics and stimulants, have increased nationwide, preventing providers and patients from accessing essential medications for treatment," the GAO said.
In 2017, West Virginia, one of the states hit hardest by the epidemic, sued the DEA, challenging the agency's quotas.
"This lawsuit sought reform to the quota-setting process that would adjust sales figures to account for the rate at which opioids are diverted from legitimate medical uses," Morrisey wrote in his Oct. 23 filing. "And as a result, the DEA undertook regulatory modifications designed to correct past practices."
Under the new "Quotas Rule," the DEA was required to account for diversion in the quota process.
On a parallel path, Congress in 2018 passed the Support Act, a legislative package including a provision that directed the DEA to specifically estimate "diversion" and also consider mortality and abuse rates.
In its notice in the Federal Register in September, the agency said it tried to estimate opioid diversion for the 2020 quota based on mortality and abuse rates, as required by the new law - and could not do it. The agency said it received overdose and death data from the Centers for Disease Control and Prevention and state attorneys general and reviewed scholarly articles and other data sets. "This information could not be used in setting the Aggregate Production Quotas," the notice said.
The notice said that federal data on overdose deaths is not precise enough to allow the DEA to target specific drugs for quota reductions.
"For example, patients that overdose from hydrocodone, oxycodone, or hydromorphone are grouped together under opioid-related overdose," the notice said. "DEA is unable to determine the basic class that led to the overdose from this information. Additionally, DEA cannot determine from the data if the patient overdosed on an illicit opioid or an FDA-approved opioid product."
Partridge also said there is no national database that collects reports of fraudulent prescriptions and other indications that drugs are being diverted to the black market, aside from the theft reports and seizures of illegal drugs.
"I don't know how we can measure diversion and how you can reduce the quota of drugs for legitimate medical use based on diversion," Partridge said.
In his October letter to Acting DEA Administrator Uttam Dhillon, Durbin said he was "discouraged" by the DEA's Sept. 12 notice that it estimated diversion based "on reported theft loss and seizures, not data on drug sales, overdoses, or deaths."
"While I appreciate the challenges in directly linking patient overdoses to a specific controlled substance, it defies logic that DEA would simply ignore or discard this information," Durbin wrote.
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On Oct. 1, the inspector general of the Justice Department released a report that poured gasoline on the issue. The report concluded that the DEA was "slow to respond" to the opioid epidemic and approved significant increases to the oxycodone manufacturing quota even as overdose deaths were rising.
The report generated headlines across the country and was embraced by the drug industry, which was being accused in a landmark lawsuit in Cleveland of causing the epidemic.
"Today's report by the Inspector General highlights many concerns that distributors have consistently raised around the DEA's oversight of the opioid epidemic, and, notably, the fact that previous DEA leadership consistently raised production quotas for opioids," the Healthcare Distribution Alliance, which represents drug distributors, said in a statement.
The IG report said there was a 400% rise in the oxycodone quota from 2002 to 2013 as deaths were rising. But the IG's report included in its calculation a 25% emergency reserve of oxycodone that was never put into production and was added in 2013 to protect against possible shortages in the event of war, natural disaster or terrorist attack.
The IG also made a mathematical error. The percentage increase from 34,482 to 153,750 kilograms is 346, not 400. After being alerted to this by The Post recently, the IG office revised the report by adding an asterisk directing readers to a footnote: "Stated otherwise, this represents an increase in the APQ of 346 percent from 2002 to 2013." Eliminate the 25% reserve and the overall quota rise drops to 257%.
The IG credits DEA acting administrator Chuck Rosenberg with lowering the quota for oxycodone by making a "significant reduction" in 2017. But what Rosenberg actually did was to remove the 25% emergency reserve, according to the current and former agency officials.
A spokeswoman for the IG said the office obtained its data from the DEA, which reviewed the report "prior to publication to confirm its accuracy."
DEA officials say that the agency has not had data that is either precise or reliable enough from the states or federal agencies to allow the agency to adjust the quota to reflect opioid abuse and overdose deaths.
"We are going to continue to ask," a senior DEA official said. "We are hopeful that more and more folks will give us this data. We will continue to look and evaluate, but we can only do with what we have. And it all has to be legally defensible."
Morrisey praised the DEA for taking steps to try to better use the quota as a tool to combat opioids.
"We are finally starting to see some real shifts," Morrisey said. "But everything is not going to get fixed overnight."
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The Washington Post's Steven Rich, Lenny Bernstein, Meryl Kornfield and Alice Crites contributed to this report.